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Not yet recruitingNCT07870421HEXCARE-PDACUpdated Oct 13, 2026

A Study Looking at Whether a Nutritional Composition Can Help People With Pancreatic Cancer Stay Stronger and Better Tolerate Chemotherapy

An interventional study of A novel cancer-specific high energy high protein medical nutrition solution and A commercially available isocaloric isonitrogenous medical nutritional solution. in Pancreatic Ductal Adenocarcinoma (PDAC), sponsored by Nutricia Research. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by Nutricia Research (part of Danone) · Not applicable, Interventional, and Supportive care

Updated Oct 13, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
216
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

The HEXCARE-PDAC study is a Phase III, randomized, double-blind, controlled, multicenter trial evaluating the effectiveness of a cancer-specific oral nutritional supplement in preserving skeletal muscle mass and improving chemotherapy tolerance in adults with non-metastatic pancreatic ductal adenocarcinoma (PDAC) receiving neoadjuvant FOLFIRINOX-based chemotherapy. The study aims to determine whether targeted nutritional intervention can mitigate cancer-associated muscle loss and improve treatment delivery and clinical outcomes in patients with PDAC

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Conditions studied

  • Pancreatic Ductal Adenocarcinoma (PDAC)
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In context

Lead sponsor

Nutricia Research is the lead sponsor of 51 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients with pancreatic ductal adenocarcinoma (PDAC) who are scheduled to be treated with (modified) FOLFIRINOX* chemotherapy (* or NALIRIFOX if that becomes the standard of care during the study per recognized (inter)national guidelines) as first therapy after initial diagnosis of PDAC
  2. ECOG performance score 0 or 1
  3. Age 18 years or above
  4. Written informed consent

Exclusion criteria

Exclusion Criteria:

  1. Patients with metastatic PDAC (i.e. confirmed distant metastases or otherwise confirmed by local practice)
  2. Patients who received prior treatment for PDAC
  3. Life expectancy \< 3 months
  4. Clinically significant dysphagia, gastrointestinal obstruction or any other condition preventing adequate oral intake to reasonably comply with the protocol recommendation of taking 2 servings of study product per day in the opinion of the Investigator
  5. Presence of an ileostomy or ileal pouch. Participants with an ileostomy at or near the terminal ileum may be enrolled if, in the opinion of the Investigator, the ileostomy does not affect the absorption of nutrients other than sodium, potassium, and water
  6. Severe renal dysfunction (estimated Glomerular Filtration Rate (eGFR) \<29 mL/min/1.73m2 or albumin: creatinine (ACR)>30) or other clinically significant renal dysfunction in the opinion of the Investigator
  7. Hepatic encephalopathy regardless of etiology, reflecting clinically significant hepatic dysfunction that may interfere with metabolic stability, cognition, or safe participation in the study in the opinion of the Investigator
  8. Pancreatic insufficiency uncontrolled by enzyme therapy or uncontrolled metabolic conditions such as diabetes mellitus or phenylketonuria, that may compromise the patient's safe participation in the study, in the opinion of the Investigator
  9. Severe hypercalcemia, i.e. total calcium level corrected for albumin >14.0mg/dL (>3.5mmol/L)
  10. Known allergy or intolerance to any of the ingredients of the study products
  11. Known pregnancy or lactation
  12. Current alcohol or drug abuse in the opinion of the Investigator
  13. Participant not capable of understanding or not willing to adhere to the study procedures and/or other protocol requirements in the opinion of the Investigator
  14. Participation in any other studies involving investigational or marketed products within 14 days prior to screening and/or during the intervention period
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
216 participants (estimated)

Study arms

  • Experimental
    Test product

    The test product is a food for special medical purposes (FSMP), it is a novel cancer-specific high energy high protein medical nutrition solution.

    Dietary Supplement: A novel cancer-specific high energy high protein medical nutrition solution

  • Experimental
    Control Product

    The control product is a commercially available isocaloric isonitrogenous medical nutritional solution.

    Dietary Supplement: A commercially available isocaloric isonitrogenous medical nutritional solution.

Interventions

  • Dietary supplementA novel cancer-specific high energy high protein medical nutrition solution

    Dietary Supplement

  • Dietary supplementA commercially available isocaloric isonitrogenous medical nutritional solution.

    Dietary Supplement

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What researchers measure

Primary outcomes

  1. Skeletal Muscle Index

    The primary outcome parameter is the difference between test and control group in the mean change from baseline to the end of neoadjuvant chemotherapy in skeletal muscle mass, expressed as skeletal muscle index (SMI) \[cm2/m2\] as measured with a CT scan on the third lumbar vertebra (L3) level as skeletal muscle area (SMA) \[cm2\] corrected for height \[m\].

    Time frame: From enrollment to the end of intervention at 12 weeks, max product intake up to 28 weeks

Secondary outcomes

  1. Cumulative Relative Dose Intensity

    The key secondary outcome parameter is the difference between test and control group in the mean Cumulative Relative Dose Intensity (cRDI) of FOLFIRINOX or mFOLFIRINOX assessed at the end of neoadjuvant chemotherapy \[%\].

    Time frame: From enrollment to the end of intervention at 12 weeks, max study product intake up to 28 weeks

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT07870421
Lead sponsor
Nutricia Research
Responsible party
Sponsor
First posted
Oct 13, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
Sep 1, 2029 (estimated)
Completion
Mar 1, 2030 (estimated)
Last update
Oct 13, 2026

Study contacts

Danone Global Research & Innovation Center B.V Danone Global Research & Innovation Center B.V
Contact
register.clinicalresearchnutricia@danone.com
+31 30 2095 000

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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